在多发性骨髓瘤临床试验中使用和报告患者报告结果的指导方针
Edward Laane1, Sam Salek2, Esther Natalie Oliva3
1Hematology-Oncology Clinic, Tartu University, 50406 Tartu, Estonia.
Cancers
|December 23, 2023
概括
患者报告的结果 (PROs) 对于评估多发性骨髓瘤 (MM) 的生活质量 (QoL) 是至关重要的. 本研究提供了基于证据的指导方针,用于MM临床试验中使用和报告PRO,以改善患者护理和治疗决策.
科学领域:
- 血液学 血液学 血液学
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 活跃多发性骨髓瘤 (MM) 由于疾病负担和治疗症状,显著影响患者的生活质量 (QoL).
- 越来越多地强调以患者为中心的护理和优化MM治疗目标中的QoL.
- 患者报告的结果 (PROs) 对于从患者的角度评估治疗有效性至关重要.
研究的目的:
- 在多发性骨髓瘤 (MM) 临床试验中制定基于证据的指导方针,用于患者报告的结果措施 (PROM) 的使用和报告.
- 为在MM临床研究中选择PROM,给药方法和数据处理提供建议.
- 确保PRO数据收集和报告标准化,以改善治疗结果和患者知情选择.
主要方法:
- 根据欧洲血液学协会 (EHA) 的核心指导方针开发方法,制定指导方针.
- 在MM临床试验中基于证据的PROM现行实践的综合和综述.
- 制定涵盖PROM选择,管理,时间,数据最小化,样本大小和报告的建议.
主要成果:
- 在MM临床试验中选择PROM的确定的一般考虑因素.
- 提供了关于PROM实施和报告的各个方面的具体建议.
- 针对策略,以尽量减少缺失的数据,并确保适当的样本大小计算.
结论:
- 在MM临床试验中对PRO的标准化使用和报告是有必要的.
- 这些指南旨在加强将患者观点纳入MM研究和临床实践.
- 实施这些建议可以改善MM患者的治疗决策和更好的QOL.
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